Kornimate/medical-research-clean huggingface dataset:
proof-of-concept study to evaluate the safety and efficacy of tryptophan in patients with bph.

Conditions: BPH; LUTS(Lower Urinary Tract Symptoms)

Summary: benign prostatic hyperplasia (bph) is one of the most prevalent human diseases and a major cause of lower urinary tract symptoms (luts). some men respond to current medical treatment (mainly α-1 adrenoreceptor antagonists and 5 α-reductase inhibitors), but a large proportion of patients continues to need a surgical procedure to treat resistant luts or even more serious complications of bph, creating the emerging necessity for novel pharmacological therapies. oxitriptan may have a possible positive effect on bph associated symptoms with probably no impact in sexual function (which is a common side effect of the current drugs for bph associated symptoms). also, improvement in symptoms could be higher than that of current drugs used for this condition. this is a single-center parallel group, randomized clinical trial. the study will take place in hospital de braga (urology department). eligible patients will be randomized to receive tamsulosin 0.4mg (once a day, q.d.) or 5-htp (5-hidroxitriptophan) 100mg (three times a day, t.i.d.), for 6 months.


Eligibility criteria:
inclusion criteria: * written informed consent; * male patients with bph for which tamsulosin is the therapeutic option per soc; * aged ≥50 and less than 75 years old; * with prostate volume ≥30 cm3 by trus; * diagnosed with luts defined by a stable ipss total score ≥13 points. exclusion criteria: * patients with post-void bladder residual volume ≥250 ml; * patients with intravesical obstruction from any cause other than bph; * history of any procedure considered an intervention for bph; * patients with active urinary tract infection; * history of recurrent urinary tract infections; * current prostatitis or diagnosis of chronic prostatitis; * history of prostate or invasive bladder cancer; * use of 5 α-reductase inhibitors within 6 months; * phytotherapy within 2 weeks before entry; * use of serotonin reuptake inhibitors or monoamine oxidase inhibitors; * patients with acute or chronic kidney failure; * patients with diagnosed or suspicion of intolerance to lactose; * patients submitted to general anesthesia in the past 4 weeks; * known intellectual disability that may hampers giving informed consent and would make the patient inappropriate for entry into this study, in the judgment of the investigator.

Keywords: bph luts 5-htp oxitriptan tamsulosin
a study to evaluate the impact on skin (injection site) reactions of taking an antihistamine (zyrtec®) or placebo prior to daily injections of copaxone®.

Conditions: Multiple Sclerosis

Summary: this study is designed to compare injection skin (injection site) reactions when an antihistamine (zyrtec®) or placebo is taken prior to performing daily copaxone® injections. patients will be assigned (like a flip of a coin) to take either a placebo or an antihistamine (zyrtec®) prior to performing their daily copaxone® injections. the patient and physician will be unaware whether they are taking a placebo or antihistamine during the study.


Eligibility criteria:
inclusion criteria: * male or female * 18 years of age or older * diagnosis of rrms * beginning or recently (within \< 3months) began self-injecting copaxone® exclusion criteria: * taking any other immunomodulatory therapy in conjunction with copaxone® * unable to perform subcutaneous self-injection * pregnant or trying to become pregnant, or breast feeding during the study * previously participated in this study or in another clinical trial in the past 30 days
using dexpanthenol cream to prevent lip corner cracks in children after tonsil/adenoid surgery

Conditions: Cheilitis, Angular; Postoperative Complications; Adenotonsillar Hypertrophy

Summary: soreness and cracking at the corners of the mouth, a condition called angular cheilitis, can be an uncomfortable problem for children after they have surgery to remove their tonsils and adenoids. this study looks at whether applying a moisturizing cream containing dexpanthenol to the corners of the mouth right before the surgery can help prevent this from happening. the main idea (hypothesis)i the investigators are testing is that this dexpanthenol cream will protect the skin and reduce the number of children who get these painful lip sores after their operation. to find this out, children who are scheduled to have tonsil and/or adenoid surgery will be invited to join the study. children (participants) will be randomly placed into one of two groups by chance. one group of children will have the dexpanthenol cream applied to their lip corners just before their surgery. the other group will not have any cream applied to their lip corners before surgery. after the surgery, investigators will check all children to see if they have developed lip corner sores and compare how many children in each group experienced this problem. the goal of this research is to see if this simple cream application can be an easy way to help children feel more comfortable while they are recovering from their surgery.


Eligibility criteria:
inclusion criteria: * age between 3 and 15 years, inclusive * scheduled for adenotonsillectomy (for indications such as obstructive sleep apnea and/or recurrent tonsillitis/adenotonsillitis). * written informed consent provided by parents or legal guardians. exclusion criteria: * known allergy or hypersensitivity to dexpanthenol or any components of the cream. * presence of angular cheilitis at the time of preoperative assessment. * use of topical or systemic steroids or antibiotics within \[örneğin, 2 weeks\] prior to surgery that might affect oral healing. * participants with known systemic diseases or conditions that might impair wound healing (e.g., uncontrolled diabetes, immunosuppressive disorders). * known diagnosis of iron deficiency and/or vitamin b12 deficiency prior to surgery.

Keywords: cheilitis, angular tonsillectomy adenoidectomy dexpanthenol pain pediatrics
radiotherapy or imiquimod in complex lentigo maligna

Conditions: Lentigo Maligna

Summary: the purpose of this study is to investigate the effectiveness of using either radiotherapy (rt) or imiquimod (imiq) to treat the lentigo maligna (lm), when surgery is not possible, is refused, or fails.

surgery is the standard treatment for people diagnosed with lm. however for some people, it may not be possible due to the location of their lm lesion(s). currently, the australian and new zealand melanoma treatment guidelines recommend radiotherapy for the treatment of lm however there is no clinical trial evidence for this and a trial is needed to prove which treatment is safer and more effective. some clinicians may also recommend the use of a cream called imiquimod. it is approved and widely used in australia to treat solar keratosis, superficial basal cell carcinoma, external genital warts, and perianal warts. although not currently licensed for treatment use in lm, there is some evidence to suggest that it is both safe and effective in treating lm. this trial will scientifically evaluate and compare these two treatments in a controlled clinical setting. the primary objective of this trial is to compare the rate of lm treatment failure and recurrence rate measured at 24 months (primary endpoint), and measured at 6, 12 months (secondary endpoints) following treatment with imiq or rt. for this study, treatment failure includes both the recurrence and persistence of lm, and is defined as the presence of lm cells within the original field of treatment confirmed by histopathology.

Eligibility criteria:
inclusion criteria: 1. aged 18 years or older. 2. a biopsy-proven lm. this includes previous treatment failures (not with imiquimod or rt) of lm that are diagnosed as biopsy-proven lm. 3. lm that is in a location amenable to treatment with imiquimod and radiotherapy. 4. willing and able to comply with study requirements. 5. written informed consent. exclusion criteria: 1. invasive melanoma. 2. medical or psychiatric condition that compromises the ability of the patient to complete protocol treatment or follow-up assessments. 3. patients who are pregnant or lactating. women of child bearing potential must have a confirmed negative urine pregnancy test at study entry. 4. life expectancy of less than 2 years. 5. radiotherapy sensitivity syndrome

Keywords: lentigo maligna imiquimod radiotherapy
antibiotic study for dental implants

Conditions: Periodontitis

Summary: this study is for people at least 21 years old who have signs of problems, like swollen gums and shrinking bones, by dental implants.

at visit 1, the dentist will: * do an oral exam * ask some questions * decide if the person qualifies for being in the study * make an appointment for visit 2 if they qualify at visit 2 (baseline), the dentist will: * do a special cleaning of the implants * examine the whole mouth * collect some fluid * take x-rays * put the people into one of two groups (taking into account whether or not they smoke) 1. one group will have the study antibiotic put on all the areas in their mouth with gum problems 2. the other group will not receive the antibiotic at visit 3 (about a month later), only fluid samples will be collected. at visit 4 (about 3 months later), the dentist will: * collect fluid samples * examine the whole mouth * apply the antibiotic again for people in that group at visit 5 (about 6 months later), the dentist will: * collect fluid samples * examine the whole mouth * take x-rays

Eligibility criteria:
inclusion criteria: * 21 years of age and good general health * appropriately documented informed consent * willing to adhere to the study schedule, prohibitions and restrictions specified in the protocol * female subjects must meet the pregnancy and contraceptive requirements * must have oral health appropriate for study inclusion exclusion criteria: * oral health inappropriate for study inclusion * females self-reporting pregnancy or lactation, or having a positive urine pregnancy result * reporting any of the following conditions: * allergy to a tetracycline-class drug * systemic medical conditions requiring antibiotic prophylaxis prior to invasive dental procedures * active systemic infectious disease such as hepatitis, human immunodeficiency virus (hiv) or tuberculosis * diagnosed with clinically significant or unstable organic disease, or compromised healing potential, heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement * participation in a dental clinical trial or use of an investigational drug within 30 days of enrollment * employees of the investigator or study center, with direct involvement in the proposed study or other studies, as well as family members of the employees or the investigator * anyone who the investigator determines should not be included in the study for any reason that could compromise safety or the analysis of study results

Keywords: peri-implantitis; antibiotic
nimotuzumab combined with vmat in elderly patients with nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: to evaluate the efficacy and toxicity of nimotuzumab combined with vmat in the treatment of elderly patients with nasopharyngeal carcinoma (\> 70 years old), and to provide high-level clinical evidence for the optimal treatment of elderly patients with nasopharyngeal carcinoma.

the incidence of elderly patients with nasopharyngeal carcinoma is increasing with a rapidly ageing population. however, the prognosis is worse than that of young patients. some patients can benefit from intensive treatment such as concurrent chemoradiotherapy, but are always with obvious toxicity. with the advancement of radiotherapy technology and the emergence of molecular targeted drugs, radiotherapy combined with nimotuzumab has shown good therapeutic efficacy and tolerance. the investigators plan to testify vmat combined with nimotuzumab in elderly patients with nasopharyngeal carcinoma.

Eligibility criteria:
inclusion criteria: * pathology confirmed squamous cell carcinoma of nasopharynx; aged ≥ 70 years old; stage iii-ivb diseases according to 8th ajcc staging; treatment for the first time; ecog scores ≤ 1; normal hepatic, renal and bone-marrow function; ace-27 scores ≤2; life expectancy≥12 weeks; can understand and sign the consent. exclusion criteria: * past malignancies history (except for non-melanoma skin cancer or cervical carcinoma in situ or cured prostate cancer of early stage); allergic to nimotuzumab; severe comorbidities including cardiovascular, cerebral vascular, mental and uncontrolled diabetes disease; chemotherapy, surgery or other molecule-target treatment; severe malnutrition.

Keywords: vmat nimotuzumab elderly patients efficacy toxicity
pharmacokinetics of caspofungin

Conditions: Septic Shock; Fungal Infection; Critical Illness

Summary: the objective of this study is to describe the pharmacokinetics of standard doses of caspofungin in critically ill patients.

this is a prospective observational study performed on critically ill patients. inclusion criteria are: severe sepsis on admission requiring broad-spectrum antibiotics. both medical and surgical patients will be included. any type of infections will be included (pulmonary, abdominal, urinary tract, etc.) antibiotics regimen includes: broad spectrum anti-bacterial antibiotics plus caspofungin (70 mg i.v. on the first day day, and 50 mg i.v. on the consecutive days, once daily. blood samples (3 ml) will be collected 2, 4, 8,12 and 24 hours after each dose of caspofungin for 3 consecutive days. the standard arterial canula will be used to obtain samples. 30 minutes after each sample collection, blood will be centrifuged for 10 minutes at 3,000 rpms. subsequently, supernatant will be collected and frozen. serum caspofungin concentration will be measured with high performance liquid chromatography. each patient's hemodynamics parameters will be recorded with the use of transpulmonary thermodilution technique (picco). other therapies i.e.: ventilatory support, sedation, an antifungal agent will be given as required.

Eligibility criteria:
inclusion criteria: * patients who require icu treatment due to severe sepsis age * 18-80 years * an eligible consent obtained from the patient or his/her attendant exclusion criteria: * allergy to caspofungin * lack of consent to participate in the study * age of patients below 18 or above 80 years

Keywords: caspofungin pharmacokinetics
a study of inotuzumab ozogamicin in chinese patients with relapsed or refractory acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia

Summary: this is an open-label, single-arm, multicenter study in chinese patients with relapsed or refractory cd22-positive b-cell all. the objective of the study is to confirm the efficacy, safety, and pk of inotuzumab ozogamicin in patients with relapsed or refractory b-cell all from mainland china.


Eligibility criteria:
inclusion criteria: * male or female participants, age 18 years or older at screening. * relapsed or refractory cd22-positive all. * subjects with philadelphia chromosome-positive (ph+) all must have failed standard treatment with at least one tyrosine kinase inhibitor. * patients in salvage 1 with late relapse should be deemed poor candidates for reinduction with initial therapy. * patients with lymphoblastic lymphoma and bone marrow involvement ≥5% lymphoblasts by morphologic assessment. * ecog performance status 0-2. * adequate renal and hepatic function, and negative pregnancy test for women of childbearing potential. exclusion criteria: * subjects with isolated extramedullary relapse or active central nervous system (cns) leukemia. * prior allogeneic hematopoietic stem cell transplant (hsct) or other anti-cd22 immunotherapy within 4 months, or active graft versus host disease (gvhd) at study entry. * evidence or history of veno-occlusive disease (vod) or sinusoidal obstruction syndrome (sos).
regulation of coagulation in orthopedic surgery to prevent deep vein thromboembolism (dvt) and pulmonary embolism (pe). a study of bay59-7939 in the prevention of venous thrombo embolism (vte) in subjects undergoing elective total knee replacement.

Conditions: Venous Thromboembolism

Summary: the purpose of this study is to assess if 10 mg bay59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.


Eligibility criteria:
inclusion criteria: * male and female patients aged 18 years or above * patients scheduled for elective total knee replacement exclusion criteria: * active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin (lmwh) * contraindication listed in the labeling or conditions precluding subject treatment with enoxaparin or requiring dose adjustment (e.g. severe renal impairment, please refer to the local label of enoxaparin in your country) * conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media)

Keywords: prevention of venous thromboembolism
a randomized controlled comparative study of ultrasound-guided paravertebral blocks as part of a multimodal regimen for ambulatory breast cancer surgery

Conditions: Breast Diseases

Summary: general anesthesia and morphine based pain medicine analgesia has been the mainstay of practice in breast cancer surgery at women's college hospital. there is evidence to suggest that patients have a better recovery, with less pain and nausea and vomiting when nerve blocks or freezing of nerves are given in addition to a general anesthetic. specifically for breast cancer surgery, evidence has suggested that the use of paravertebral blocks provide patients with a better quality of recovery after surgery. the aim of this study is to examine whether patients who receive the nerve blocks using an ultrasound machine in addition to general anesthesia have a better quality of recovery than patients who receive a general anesthetic alone. the hypothesis is that patients receiving ultrasound-guided paravertebral blocks (pvb) with propofol-based general anesthesia (ga) will have a better quality of recovery than patients receiving general anesthesia-opioid-analgesia. quality of recovery will be assessed using a modification of the qor-27, a validated instrument to assess postoperative recovery in an ambulatory surgical population.


Eligibility criteria:
inclusion criteria: * patients diagnosed with breast cancer at stage t1-3, n0-2, m0, presenting for unilateral complete or partial mastectomy with or without sentinel lymph node dissection, with or without implant insertion * asa physical status i-ii * 18-85 years of age, inclusive * bmi ≤ 35 exclusion criteria: * contraindications to paravertebral nerve block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the back area) * pregnancy * history of alcohol or drug dependency/abuse * history of significant psychiatric conditions that may affect patient assessment
rapid cadence cycling for parkinson's disease: a study of implementation and efficacy in the community setting

Conditions: Parkinson Disease

Summary: forced cadence cycling (fcc) in which individuals with parkinson's disease (pd) pedal with external augmentation at 80-90 revolutions per minute (rpm) has demonstrated significant motor improvement in prior clinical trials. these studies required either a tandem bicycle with second rider or an expensive motorized bicycle, making this therapy inaccessible to most patients. in this pragmatic open-label before and after pilot study investigators examine implementation and effectiveness of (rcc) without tandem or motor augmentation and in a community-based setting. approximately 30 participants will be recruited to participate in 24 one-hour rapid-cadence spin classes in ymcas over 8 weeks. primary outcomes will examine implementation of the intervention and secondary outcomes will examine effectiveness against a historical comparison group.


Eligibility criteria:
inclusion criteria: 1. adults age 18 or older. 2. clinically confirmed diagnosis of idiopathic pd by a movement disorder specialist. 3. hoehn and yahr stage i-iii while on anti-parkinsonian medication. 4. stable or absent mao-b inhibitors (selegiline, rasagiline, zydis selegiline hcl oral disintegrating) for at least 60 days prior to enrollment; stable or absent other medications for pd motor symptoms (levodopa, dopamine agonists, anticholinergics, amantadine, comt-inhibitors) for at least 30 days prior to enrollment; stable or absent medications for the following pd-non-motor symptoms: depression, anxiety, cognition, sleep, orthostatic hypotension. 5. agreement to defer any medication changes until after completion of 8-week program and post-test measurements. 6. written permission by a physician to participate in the program. 7. english language proficiency sufficient to understand and participate in a cycling class taught in english. exclusion criteria: 1. clinically significant medical disease that would increase the risk of exercise-related complications (eg: cardiac or pulmonary disease, uncontrolled diabetes mellitus, uncontrolled hypertension or stroke) as determined by a treating physician through letter obtained by ymca or the study investigator. 2. dementia as evidenced by a score of less than 116 on the mattis dementia rating scale or dementia in the opinion of the study investigator that would prohibit subject from complying with all study activities. 3. other medical or musculoskeletal contraindication to exercise. 4. concurrent participation in another trial of exercise therapy for pd or initiation of a new structured exercise plan during the duration of the study. note: participants may continue any pre-existing exercise routine (including group-based classes) during the study but will be asked not to start anything new.
differences in nerve fiber layer between patients with normal- and high-pressure-glaucoma

Conditions: Normal Tension Glaucoma; High Tension Glaucoma

Summary: the purpose of the study is to prove if there is any difference in the nerve fiber layer between patients with normal- and high-tension-glaucoma with similar structural optic nerve head parameters.

it is till now not definitely clear whether normal- and high-tension glaucoma are different forms of the same disease and whether they have similar pathogenetic mechanisms. spectral domain optical coherence tomography (sd-oct) is supposed to objectively evaluate retinal nerve fiber layer (rnfl) thickness. the investigators propose a study to compare the rnfl in patients with normal- and high-tension-glaucoma. in order to exclude other possible differences,which could influence the results, only patients with similar structural optic nerve head damage in both groups will be compared.

Eligibility criteria:
inclusion criteria: * persons over 18 years * men or women * with normal- and high-tension glaucoma exclusion criteria: * cataract * cloudy cornea and other conditions with bad visualisation quality of optic nerve head * optic nerve atrophy except glaucomatous